有效的工藝驗(yàn)證對(duì)保證藥品質(zhì)量至關(guān)重要，2011年1月24日，F(xiàn)DA發(fā)布了工藝驗(yàn)證指南《Process Validation: GeneralPrinciples and Practices》。該指南概況了工藝驗(yàn)證的一般原則和方法，將工藝驗(yàn)證與產(chǎn)品生命周期概念以及現(xiàn)有的FDA/ICH指南進(jìn)行了整合，如Q8(R2)藥品研發(fā)、Q9質(zhì)量風(fēng)險(xiǎn)管理和Q10藥品質(zhì)量體系。從技術(shù)審評(píng)的角度，對(duì)FDA新版工藝驗(yàn)證指南的主要特點(diǎn)進(jìn)行討論分析。

Effective process validation contributes significantly to assuring drug quality. On January 24, 2011, the process validation guidance "Process Validation:General Principles and Practices" was issued by FDA. This guidance overviews general principles and methods of process validation, aligns process validation activities with a product lifecycle concept and with existing FDA/ICH guidance, including Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. In this article, the main characteristics of FDA new guidance for process validation are discussed from the view of technical review.

協(xié)和青年科研基金資助項(xiàng)目（3332015102）；中國(guó)醫(yī)學(xué)科學(xué)院放射醫(yī)學(xué)研究所發(fā)展基金資助項(xiàng)目（1537）